Optimal rTMS for Cognitive Deficits and Negative Symptoms in Schizophrenia
Optimizing Treatment Protocol of High Frequency Repetitive Transcranial Magnetic Stimulation for Cognitive Deficits and Negative Symptoms in Schizophrenia: an Exploratory Study
1 other identifier
interventional
90
1 country
1
Brief Summary
Negative symptoms and cognition decline are major challenges in clinical management of schizophrenia. Dorsomedial prefrontal cortex (DLPFC) has been highly involved in the mechanisms of negative symptoms and cognitive symptoms of schizophrenia. However, the effect of repetitive transcranial magnetic stimulation (rTMS) over left or bilateral DLPFC has not yet been well studied. The aim of this study is to describe how the effectiveness of rTMS over different targets for cognitive deficits and negative symptoms in schizophrenia will be evaluated. The study will provide evidence to determine whether a bilateral DLPFC rTMS and is more effective than a left DLPFC rTMS alone to optimize treatment protocol in schizophrenia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable schizophrenia
Started Jan 2020
Typical duration for not_applicable schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2020
CompletedFirst Submitted
Initial submission to the registry
October 9, 2022
CompletedFirst Posted
Study publicly available on registry
October 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedJune 22, 2023
October 1, 2022
4 years
October 9, 2022
June 20, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Mean Change From Baseline in Assessment of Negative Symptoms(SANS) Post Treatment
The Assessment of Negative Symptoms(SANS) is a standardized assessment utilizing a 6-point scale with which the clinician rates the degree to which the severity of the subject's negative symptoms. It consists of 19 items assessing five symptoms of the negative dimension: Affect flattening, alogia, avolition-apathy, anhedonia-asociality, and poor attention.
Baseline and 4 weeks
Mean Change From Baseline in MATRICS Consensus Cognitive Battery Post Treatment
The MATRICS Consensus Cognitive Batteryis a standardized rating tool to assess the severity of the subject's cognitive symptoms, which consisted of seven domains and the total score: speed of processing, attention/vigilance, working memory, visual learning, verbal learning, reasoning/problem solving, and social cognition.
Baseline and 4 weeks
Secondary Outcomes (3)
Mean Change From Baseline in Positive and Negative Syndrome Scale(PANSS)-Negative Symptoms Subscale Post Treatment
Baseline and 4 weeks
Mean Change From Baseline in Clinical Global Impression - Severity (CGI-S) Post Treatment
Baseline and 4 weeks
Mean Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Post Treatment
Baseline and 4 weeks
Study Arms (3)
Active rTMS over bilateral dorsolateral prefrontal cortex
ACTIVE COMPARATORActive rTMS over bilateral dorsolateral prefrontal cortex. Participants will receive up to 20 rTMS sessions within the 4-week treatment period.
Active rTMS over left dorsolateral prefrontal cortex
ACTIVE COMPARATORActive rTMS over left dorsolateral prefrontal cortex and sham rTMS over right dorsolateral prefrontal cortex. Participants will receive up to 20 rTMS sessions within the 4-week treatment period.
Sham rTMS over bilateral dorsolateral prefrontal cortex
SHAM COMPARATORSham rTMS over bilateral dorsolateral prefrontal cortex. Participants will receive up to 20 rTMS sessions within the 4-week treatment period.
Interventions
Active treatments with repetitive transcranial magnetic stimulation (rTMS) over bilateral dorsolateral prefrontal cortex (DLPFC) took the form of intermittent theta burst stimulation (iTBS). For iTBS the stimulation parameters were: frequency = triplet 50 Hz bursts, repeated at 5 Hz; train duration = 2 s ON and 8 s OFF, total pulses/session = 600; total number of treatments = 20(5 sessions per week) at 80 % of each side resting motor threshold (MT). The rTMS target was first randomized to the left or right DLPFC, then switched to the opposite side.
Active treatments with repetitive transcranial magnetic stimulation (rTMS) over left dorsolateral prefrontal cortex(DLPFC) took the form of intermittent theta burst stimulation (iTBS). For iTBS the stimulation parameters were: frequency = triplet 50 Hz bursts, repeated at 5 Hz; train duration = 2 s ON and 8 s OFF, total pulses/session = 600; total number of treatments = 20(5 sessions per week) at 80 % of left resting motor threshold (MT). Sham rTMS stimulation was delivered over right dorsolateral prefrontal cortex(DLPFC) using the same stimulation parameters, except for using the sham stimulation coil. The rTMS target was first randomized to the left or right DLPFC, then switched to the opposite side.
Sham rTMS stimulation was delivered over bilateral dorsolateral prefrontal cortex (DLPFC) using the same stimulation parameters, except for using the sham stimulation coil. The rTMS target was first randomized to the left or right DLPFC, then switched to the opposite side.
Eligibility Criteria
You may qualify if:
- Met the Diagnostic and Statistical Manual of Mental Disorders, Five Edition (DSM-V) diagnostic criteria for schizophrenia and the diagnosis was verified by an experienced psychiatrist based on the Mini-International Neuropsychiatric Interview (MINI) 7.0 .
- Age between 18 and 60.
- Patients with prominently negative symptoms, which was defined as: PANSS negative subscore≥15 points and one of items N1-N7 scoring≥4.
- All patients were in stable clinical conditions (reduction rate of PANSS score\<10% within 4 weeks), stable antipsychotic treatment for at least 4 weeks, and able to provide informed consent.
You may not qualify if:
- Any contraindication for rTMS (e.g., intracranial metal, pacemakers, cochlear and intracranial hypertension).
- Unstable clinical condition (e.g., being aggressive and uncooperative).
- Current substance abuse.
- Any other psychiatric diagnosis.
- Significant medical condition including neurological disease, severe cardiovascular, hepatic, renal diseases.
- Previous treatment with modified electric convulsive therapy (MECT) within 3 months before enrollment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shanghai Mental Health Centerlead
- Xuhui Mental Health Centercollaborator
Study Sites (1)
Shanghai Xuhui Mental Health Center
Shanghai, Shanghai Municipality, 20030, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yan Zhan, MD
Shanghai Xuhui Mental Health Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2022
First Posted
October 31, 2022
Study Start
January 1, 2020
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
June 22, 2023
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share